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Effectiveness of a Community-level HIV/STD Prevention Intervention in Promoting Safer Sexual Behaviors in High-risk Populations

1 november 2013 bijgewerkt door: RTI International

NIMH Collaborative HIV/STD Prevention Trial

This study will evaluate the effectiveness of a community-level HIV prevention program in promoting safer sexual behaviors and reducing the transmission of HIV/sexually transmitted diseases among at-risk populations in China, India, Peru, Russia, and Zimbabwe.

Studie Overzicht

Gedetailleerde beschrijving

The HIV/AIDS epidemic remains largely out of control in many areas of the world, with an estimated 2.5 million new HIV infections worldwide in 2007. Developing countries with few economic resources and world regions undergoing difficult social transitions have been particularly impacted by large increases in HIV and sexually transmitted disease (STD) infections. To date, effective individual prevention approaches have not been rapid enough to avert the epidemic in these areas and may be too resource intensive to maintain. Behavioral HIV prevention interventions on the community level seek to reduce the prevalence of high-risk sexual behaviors by reaching large numbers of vulnerable people in a cost-effective and feasible manner, even in areas with limited resources. The Community Popular Opinion Leader (C-POL) program is an HIV prevention intervention that recruits and trains trusted opinion leaders in the community to promote safe sex behaviors through risk-reduction conversations with peers. Implementing the C-POL program in world regions facing significant HIV/AIDS epidemics may be the most effective means of encouraging behavior change among members of at-risk populations and strengthening social norms to maintain these changes. This study will evaluate the effectiveness of the C-POL program in promoting safer sexual behaviors and reducing the transmission of HIV/STDs among at-risk populations in China, India, Peru, Russia, and Zimbabwe.

Participation in this study will last 2 years. Initially, an ethnographic study will be conducted to determine the HIV/STD knowledge, attitudes, and behaviors among the population living in the target communities. Information collected via observation, focus groups, and interviews will be used to determine the social risk groups operating within the community and to identify and recruit the opinion leaders who are influential in these groups. Also, an epidemiological study will be conducted to collect information on sexual behaviors and HIV/STD rates.

A cohort of members from participating communities will first undergo baseline assessments that will include a survey about general health and knowledge of HIV/STDs and a biological sampling for HIV/STD testing. Participating communities will then be assigned randomly to receive the C-POL intervention and HIV/STD educational materials or HIV/STD educational materials alone. In communities receiving the C-POL intervention, the previously recruited opinion leaders will be taught skills for sharing HIV risk-reduction messages in daily conversation with peers. This training will occur over four to five weekly sessions. At least 15% of the community population will be trained as opinion leaders. After the initial training, opinion leaders will attend six to nine booster sessions over the next 2 years to reinforce and support continued conversation efforts. Communities assigned to receive the HIV/STD educational materials will receive informational materials on HIV/STDs to provide to community members and will provide treatment or treatment referral for people with nonviral STDs.

All participants in the baseline cohort will be asked to repeat the baseline testing 1 and 2 years later. Participants who are not able to visit a clinic for testing will be contacted by phone to complete the baseline survey. After the 2-year assessments, the C-POL intervention will be conducted in the communities that received educational materials only.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

18147

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Fuzhou, China, 350003
        • Fujian Institute of Health Education
      • Chennai, Indië, 600 113
        • YRG Centre for AIDS Research and Education (YRGCARE)
      • Lima, Peru
        • Universidad Peruana Cayetano Heredia
      • St. Petersburg, Russische Federatie, 197110
        • Biomedical Center
      • Harare, Zimbabwe
        • Zimbabwe Community Health Intervention Research (ZiCHIRe) - University of Zimbabwe

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 49 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Either lives, works, or socializes in the selected venues
  • Plans to remain in the venue for at least 1 year after study entry

Exclusion Criteria:

  • Permanent disability that hinders participation (e.g. deaf, mental retardation)
  • Reports no sex in the 6 months before study entry (China, Peru)
  • No STDs present at study entry (China)
  • Enrolled in final year of school at time of recruitment (Russia)
  • Has lived in venue for less than 2 years (Zimbabwe)
  • Lives in venue for less than 9 months out of a year (Zimbabwe)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 1
Participating communities will receive the Community Popular Opinion Leader intervention and HIV/STD educational materials.
The C-POL intervention will teach identified opinion leaders to share personalized HIV prevention messages in conversations with peers in an effort to change community norms. Opinion leaders will be taught skills for sharing HIV risk-reduction messages during four to five weekly training sessions. At least 15% of the community population will be trained as opinion leaders. After the initial training, opinion leaders will attend six to nine booster sessions over the next 2 years to reinforce and support continued conversation efforts.
Andere namen:
  • Popular Opinion Leader (POL)
  • Diffusion of Innovations
Communities will receive HIV/STD educational materials and treatment referral information to distribute to community members.
Actieve vergelijker: 2
Participating communities will receive HIV/STD educational materials only.
Communities will receive HIV/STD educational materials and treatment referral information to distribute to community members.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Frequency of unprotected sexual acts with nonspousal partners
Tijdsspanne: Measured at baseline and Years 1 and 2
Measured at baseline and Years 1 and 2
Overall observed incidence of sexually transmitted diseases (STDs) (e.g., chlamydia, gonorrhea, syphilis, trichomonas, HIV, or herpes simplex virus-2), as detected by biological specimens
Tijdsspanne: Measured at baseline and Years 1 and 2
Measured at baseline and Years 1 and 2

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Increased exposure to HIV prevention messages, more STD treatment seeking, lower stigma regarding HIV and STDs, and lower substance abuse associated with sexual behavior in intervention group as compared to control group
Tijdsspanne: Measured at Year 2
Measured at Year 2

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Carlos F. Caceres, PhD, Cayetano Heredia University, Lima, Peru
  • Hoofdonderzoeker: David D. Celentano, ScD, The Johns Hopkins University, Baltimore, Maryland (India)
  • Hoofdonderzoeker: Thomas J. Coates, PhD, University of California at Los Angeles, Los Angeles, California (Peru)
  • Hoofdonderzoeker: Tyler D. Hartwell, PhD, RTI International, Research Triangle Park, North Carolina (DCC)
  • Hoofdonderzoeker: Danuta Kasprzyk, PhD, Battelle Center for Public Health Research and Evaluation, Seattle, Washington (Zimbabwe)
  • Hoofdonderzoeker: Jeffrey A. Kelly, PhD, Medical College of Wisconsin, Milwaukee, Wisconsin (Russia)
  • Hoofdonderzoeker: Andrei P. Kozlov, PhD, Biomedical Center, St. Petersburg State University, St. Petersburg, Russia
  • Hoofdonderzoeker: Willo Pequegnat, PhD, National Institute of Mental Health, Bethesda, Maryland
  • Hoofdonderzoeker: Mary Jane Rotheram-Borus, PhD, University of California at Los Angeles, Los Angeles, California (China)
  • Hoofdonderzoeker: Suniti Solomon, MD, YRG Centre for AIDS Research and Education, Chennai, India
  • Hoofdonderzoeker: Godfrey B. Woelk, PhD, University of Zimbabwe Medical School, Harare, Zimbabwe
  • Hoofdonderzoeker: Zunyou Wu, MD, PhD, Chinese Center for Disease Control and Prevention, Beijing, P.R. China

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2002

Primaire voltooiing (Werkelijk)

1 augustus 2007

Studie voltooiing (Werkelijk)

1 augustus 2007

Studieregistratiedata

Eerst ingediend

30 juni 2008

Eerst ingediend dat voldeed aan de QC-criteria

30 juni 2008

Eerst geplaatst (Schatting)

3 juli 2008

Updates van studierecords

Laatste update geplaatst (Schatting)

3 november 2013

Laatste update ingediend die voldeed aan QC-criteria

1 november 2013

Laatst geverifieerd

1 juli 2008

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • U10MH061537 (Subsidie/contract van de Amerikaanse NIH)
  • DAHBR 9A-ASGT
  • U10MH061499 (Subsidie/contract van de Amerikaanse NIH)
  • U10MH061513 (Subsidie/contract van de Amerikaanse NIH)
  • U10MH061536 (Subsidie/contract van de Amerikaanse NIH)
  • U10MH061543 (Subsidie/contract van de Amerikaanse NIH)
  • U10MH061544 (Subsidie/contract van de Amerikaanse NIH)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op HIV-infecties

Klinische onderzoeken op Community Popular Opinion Leader (C-POL)

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Abonneren